Randomised controlled trial of a behaviour change physiotherapy intervention to increase physical activity following hip and knee replacement: the PEP-TALK trial

OBJECTIVE: To test the effectiveness of a behaviour change physiotherapy intervention to increase physical activity compared with usual rehabilitation after Total Hip Replacement (THR) or Total Knee Replacement (TKR). DESIGN: Multicentre, pragmatic, two-arm, open, randomised controlled, superiority trial SETTING National Health Service providers in nine English hospitals. PARTICIPANTS: 224 individuals aged >18 years, undergoing a primary THR or TKR deemed “moderately inactive” or “inactive”. INTERVENTION: Participants received either six, 30-minute, weekly, group-based exercise sessions (usual care), or the same six-weekly, group-based, exercise sessions each preceded by a 30-minute cognitive behaviour discussion group aimed at challenging barriers to physical inactivity following surgery (experimental). RANDOMISATION & BLINDING: Initial 75 participants were randomised 1:1 before changing the allocation ratio to 2:1 (experimental:usual care). Allocation was based on minimisation, stratifying on comorbidities, operation type and hospital. There was no blinding. MAIN OUTCOME MEASURES: Primary: UCLA Activity Score at 12 months. Secondary: six and 12 month assessed function, pain, self-efficacy, kinesiophobia, psychological distress and quality of life. RESULTS: Of the 1254 participants assessed for eligibility, 224 were included (139 experimental:85 usual care). Mean age was 68.4 years (standard deviation: 8.7), 63% were female, 52% underwent TKR. There was no between-group difference in UCLA score (mean difference: -0.03 (95% CI: -0.52 to 0.45, p=0.89)). There were no differences observed in any of the secondary outcomes at six or 12 months. There were no important adverse events in either group. The COVID-19 pandemic contributed to the reduced intended sample size (target 260) and reduced intervention compliance. CONCLUSIONS: There is no evidence to suggest attending usual care physiotherapy sessions plus a group-based behaviour change intervention differs to attending usual care physiotherapy alone. As the trial could not reach its intended sample size, nor a proportion of participants receive their intended rehabilitation, this should be interpreted with caution